Cardiovascular Systems has finished enrolling 443 patients in its first premarket approval (PMA) trial, designed to assess the safety and effectiveness of the electric orbital atherectomy system (OAS) in treating severe calcified coronary arteries.
The new electric coronary system provides physicians complete control of device operation, with minimal set up time.
The FDA investigational device exemption approved trial, ORBIT II, has randomised patients so that 343 will be treated with the company’s original pneumatic OAS and 100 with the new electric OAS.
The primary endpoints for the ORBIT II trial will be based on a 30-day patient follow-up post procedure.
Cardiovascular Systems president and CEO David Martin said; "At Tct this year, Dr Philippe Genereux presented new data proving, with statistical significance, that patients with moderate-to-severe calcium were more likely to die, and have major adverse coronary events."
Dr Genereux, director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation (CRF), collected the data from 14 randomised trials in which 11,651 patients were treated with drug-eluting stents.
Results showed statistically higher rates of death and major adverse cardiac events, including myocardial infarction, definitive stent thrombosis or ischemic target lesion revascularisation, than in patients with no or mild calcium.
Metropolitan Cardiovascular Consultants interventional cardiologist and study principal investigator Dr Jeffrey Chambers said based on promising results in the ORBIT I study, the company’s orbital technology will be well suited for removing calcified plaque in coronary lesions.
"I look forward to seeing the results from ORBIT II and I’m hopeful that we will have a new therapy in the near future for these difficult-to-treat patients."
The company anticipates that the PMA will be final on submission of module 3, which includes ORBIT II clinical data and proposed labeling.
The PMA filing, which included modules 1 (preclinical) and 2 (manufacturing/system quality), will occur in early 2013, according to the company.